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Compliance Manager

סל המשרות שלי
סל המשרות שלך ריק
משרות דומות שעשויות לעניין אותך

Omrix Biopharmaceuticals is seeking a Compliance Manager.

 

The Compliance Manager is Primarily responsible for support and management of the compliance program, ensuring that the Israeli Biologic and Medical Device Companies comply to regulatory requirements and internal procedures. This position will provide compliance support in the specific areas of Internal Audits, External Audits, and Audit Readiness, and ensure ongoing effectiveness of these systems. This position develops, and coordinates plans to identify, address and mitigate potential risks to regulatory compliance.

 

 Duties and Responsibilities

 

Collaborate with business partners to ensure compliance to all Device, Drug, and Biologic regulatory requirements, standard requirements, and internal procedures.

Establish, evaluate, and maintain the internal audit schedule and ensure that activities are carried out by staffs and relevant parties on time

Accountable to assure that all Omrix manufacturing sites and applicable suppliers are inspection ready always and that Omrix and Ethicon senior management is alerted to potential quality system compliance issues in time to mitigate or prevent.

Supervises all audit follow-up processes to ensure accurate and timely resolution of agreed actions (e.g. monitoring of corrective action plans and remediation plans) and communicates the compiled compliance data on audit results and quality metrics

Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements. Participation in task force teams to improvement quality management systems and participate in facility assessments at other J&J companies as assigned.

Supervise compliance associates according to Human Resources policies and procedures, including hiring, training, and performance appraisals. The position will provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities. Ensure all direct reports comply with Health and Safety requirements

Provides compliance training to different functions within the organization as applicable and evaluates internal auditors as applicable

Ability to interpret and apply Biologic, Drug, and Device regulatory requirements and industry best practices to consistently demonstrate correct decision making when judging the level of criticality of compliance issues, the mitigating actions required and the management level to which it must be elevated

 

Required Knowledge, Skills and Abilities

  • 5-8 years related experience in Quality, Compliance or Regulatory Affairs
  • Working knowledge of Pharmaceutical/Biological and Medical Device applicable Standards and Regulations is a must
  • Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry
  • Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units
  • Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results
  • Ability to recognize, build support for change and engage in constructive conflict.
  • High tolerance for ambiguity in a complex environment
  • Ability to make the complex clear and easily understood by others
  • Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
  • Ability to build partnerships both internally and externally

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

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